A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor Alpha (FolRα) Antibody-Drug Conjugate (ADC), in Patients With Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) and Endometrial Cancers

Trial ID # NCT03748186
Phase I
Drug Class Antibody Drug Conjugates: FRalpha
Drug Name Luveltamab tazevibulin
Alternate Drug Names STRO-002, anti-folate receptor-alpha antibody drug conjugate STRO-002
Drugs in Trial Luveltamab tazevibulin
Eligible Participant

Platinum resistant or refractory ovarian cancer

Patients Enrolled

31 patients in dose escalation; 44 patients in dose expansion, median 3 prior therapies (1-3)

Therapy Setting


Study Design

Open-Label, Non-randomized


CBR, ORR, DCR, DoR, PFS, evaluated per RECIST


Results from dose escalation, doses 2.9 mg/kg and above:

ORR: 32% (1CR, 4PR, 5uPR, n=31)
DCR (4 months): 61%
CBR: 55%
DCR (1 year): 16%
PFS: 7.2 months

Results from expansion at 4.3 mg/kg and 5.2 mg/kg:
ORR: 31.7% (13PR, n=41)
DCR: 78%
DoR: 5.4 months
PFS: 4.3 months (n=44)

Exploratory analysis, FRalpha expression by TPS %, dosing 4.3 mg/kg or 5.2 mg/kg:
Doses 4.3 mg/kg and 5.2 mg/kg:
TPS ≤ 25% (n=9): ORR: 11.1% (1PR); DoR: 2.9 months; PFS: 3.8 months
TPS > 25% (n=32): ORR: 37.5% (12PR); DCR: 81.3%; DoR: 5.5 months; PFS: 6.1 months
TPS > 25% and 4.3 mg/kg (n=16): ORR: 31.3%; DoR: 13 months; PFS: 6.1 months
TPS > 25% and 5.2 mg/kg (n=16): ORR: 43.8%; DoR: 5.4 months; PFS: 6.6 months 

Clinically Significant Adverse Events

Serious AE: febrile neutropenia (n=1)
Grade 3-4 AE: overall (86%), neutropenia (71%), arthralgia (18%), anemia (14%) - only 1 pt required therapeutic corticosteroid eyedrops


Luveltamab tazevibulin (STRO-002) is well tolerated with evidence of anti-tumor activity in heavily pretreated patients across a broad range of FRα expression levels. No ocular toxicity signals have been observed.


Naumann RW et al. Phase 1 dose-escalation study of STRO-002, an antifolate receptor alpha (FRα) antibody drug conjugate (ADC), in patients with advanced, progressive platinum-resistant/refractory epithelial ovarian cancer (EOC). J Clin Oncol (2021) 39 (suppl 15; abstr 5550)

Naumann RW et al. Poster

Oaknin A et al. Luveltamab tazevibulin (STRO-002), an anti-folate receptor alpha (FolRα) antibody drug conjugate (ADC), safety and efficacy in a broad distribution of FolRα expression in patients with recurrent epithelial ovarian cancer (OC): Update of STRO-002-GM1 phase 1 dose expansion cohort. J Clin Oncol 41, 2023 (suppl 16; abstr 5508)

Oaknin A et al. Slide from presentation

Contact Us
Contact Us

We are here to help! Send us a message below or give us a call at (858) 657-0282.